The development and assessment of a new antibiotic involve several stages, including preclinical testing, clinical trials, and post-market surveillance. These stages ensure that the antibiotic is safe, effective, and has minimal resistance risk before and after its release to the market. 1. Preclinical Assessment This stage includes laboratory and animal …
DeepakRajput 
Methods for Standardization of Antibiotics, Vitamins, and Amino Acids
The standardization of bioactive substances such as antibiotics, vitamins, and amino acids is crucial to ensure their potency, efficacy, and safety. Standardization is achieved through validated assays and procedures that determine the exact concentration, biological activity, and quality of these substances. Below are the commonly used methods for standardization: 1. …
Principles and Methods of Different Microbiological Assays
Microbiological assays are techniques used to estimate the concentration or potency of a substance (such as antibiotics, vitamins, or growth factors) by measuring its effect on a microorganism. These assays are essential in pharmacology, biotechnology, and microbiology for determining the activity of various substances in the presence of specific microbes. …
Clean Area Classification
Clean area classification is a system used to categorize environments based on the level of cleanliness required for specific activities or processes. It is a critical aspect of industries such as pharmaceuticals, biotechnology, electronics manufacturing, and healthcare, where the presence of contaminants can have significant consequences on product quality and …
Study of Different Sources of Contamination in an Aseptic Area
Understanding and identifying potential sources of contamination in an aseptic area is essential for maintaining the integrity of the sterile environment. Contamination can arise from various sources, and a comprehensive study is crucial for effective prevention. Here are different sources of contamination: 1. Personnel: Skin and Clothing Shedding: Human skin …
Laminar flow: Definition, Equipment and uses
Laminar flow refers to a smooth, regular flow of a fluid (liquid or gas) in which the fluid moves in parallel layers with minimal disruption between the layers. In laminar flow, the particles of the fluid follow streamlined paths, and their velocity and direction are well-organized. This is in contrast …
Aseptic area: Definition, design and Equipment
Designing of aseptic area Designing an aseptic area is crucial for industries like pharmaceuticals, biotechnology, and food processing, where maintaining a sterile environment is essential to prevent contamination of products. Here is a detailed note on designing an aseptic area: Facility Location and Layout Choose a location away from sources …
